This seminar will aim at understanding and scope out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation, and ensuring Data Integrity for Regulatory Compliance.
This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of stages of the Product Lifecycle. In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments and computerized systems are used daily.
Why you should attend
This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of stages of the Product Lifecycle. In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments and computerized systems are used daily.
Agenda
Session 1- Introduction
- Quality Systems, Paradigm Shift, Global Perspectives
- QA/QC Validation
- Risk Assessment
Session 2
- Measurement, Resolution, Errors, and Uncertainty
- Regulatory and QS Requirements
- The Product Life-Cycle Concept
- USP chapter 1058
- Examples of Various Systems
Session 3
- Strategies for Validation
- Documentation /Master Validation Plan
Session 4
- Training Requirements
- Examples of Various Systems
Speaker
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab.
Who Should Attend
- Scientists
- Managers
- R&D Personnel
- Quality Assurance/Quality Control Staff
- Validation Managers
- Validation Coordinators
- Production and Process Development Personnel
- Regulatory/Compliance Managers
- Chemists
- Technicians Study Directors(GLP)
- Qualified Persons (EMEA)
- Pharmaceutical Development
- CRO Staff
- CRO Managers, Accredited Laboratories in general
- Any one engaged with Test Methods
